Efficacy of Pulsed Light Therapy for Meibomian Gland Dysfunction and Dry Eye Syndrome

NCT01917539 | Withdrawn

• 1 other identifier: 20120140
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Our primary aim is to determine whether pulsed light therapy (PLT) is effective in reducing symptoms and improving clinical stigmata of dry eye syndrome (DES) associated with meibomian gland dysfunction (MGD) in patients with facial rosacea (which includes ocular rosacea). The uses of PLT are for treatment of rosacea, hair removal, pigmented lesions, and skin telangiectasias. The risks include the potential for transient sunburn-like sensations (i.e. redness, burning sensation) and particularly if not used properly, the potential to cause burns, blistering, scarring, and pigmentary changes.

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

• Anatomical improvement of the meibomian glands and their secretions.

  We are looking at subjective changes in DES symptomatology based on the OSDI questionnaire score. We are also looking at objective changes in examination findings based on the tear film properties (TBUT, Schirmer), staining patterns of the ocular surface using fluor. and LG dyes, characteristics of the meibomian glands and lid margin (e.g. telangiectasias, notching, myelography by transillumination, etc), as well as the meibum secretions (e.g. expressibility, and consistency). Change in baseline for OSDI, TBUT in seconds, Schirmer testing in mm, staining pattern score (standardized proprietary score on a scale of 1-4), myelography by % of meibomian glands that can be transilluminated, expressibility/consistency (proprietary score on scale of 1-4) will be measured.

  3 months

Study Arms (2)

Sham Treatment

SHAM COMPARATOR

Sham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment. All subjects will come for their initial visit where evaluation and treatment #1 will take place. They will also attend 3 follow-up visits spaced approximately 3-4 weeks apart during which they will have subsequent treatments and/or evaluations for their dry eyes. The visit duration will range from approximately 60-90 minutes per clinic visit.

Device: Sham Treatment

Pulsed Light Therapy

EXPERIMENTAL

All subjects will come for their initial visit where evaluation and treatment #1 will take place. They will also attend 3 follow-up visits spaced approximately 3-4 weeks apart during which they will have subsequent treatments and/or evaluations for their dry eyes. The visit duration will range from approximately 60-90 minutes per clinic visit.

Device: Pulsed Light Therapy

Interventions

Sham Treatment DEVICE

Sham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment.

Sham Treatment

Pulsed Light Therapy DEVICE

Light treatment will consist of applying eye shields used for PLT, applying the skin gel to the facial region, and applying the probe with application of pulsed light therapy treatment.

Pulsed Light Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater or equal to 18 y/o
• Patients presenting to academic referral center for DES
• Diagnosis of mild to moderate DES with meibomian gland dysfunction and ocular rosacea, based on evaluation of meibomian glands (MG), MG secretions, and other factors
• Facial rosacea
• Patients must not have started any new medications within the past 1 month
• Patients should not be using warm compresses or lid scrubs more than 1-2 times in the previous 2 weeks
• Symptomatic changes in DES

You may not qualify if:

• Age \< 18
• History of inflammatory DES (e.g. Sjogren's, rheumatoid arthritis, Stevens-Johnson syndrome, ocular cicatricial pemphigoid)
• History of trauma-induced ocular surface disease (thermal burns, chemical burns)
• Severe DES
• Pregnant women
• H/o seizures
• Significant unprotected sun exposure or use of tanning beds or creams in treated area (must be discontinued at least 2 weeks prior to treatment, during treatment course, and 2 weeks after last treatment)
• Use of Accutane, anti-coagulants, or St. John's Wort
• Active infections/immunosuppression
• Herpes 1 or 2 within the treatment area
• Patients who have undergone LASIK surgery within the past 12 months

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Wendy Lee, MD

  University of Miami Bascom Palmer Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: August 6, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

US (1)